ZEMPLAR INJECTION 5 mcgml

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

PARICALCITOL

Tilgjengelig fra:

ABBVIE PTE. LTD.

ATC-kode:

H05BX02

Dosering :

5 mcg/ml

Legemiddelform:

INJECTION

Sammensetning:

PARICALCITOL 5 mcg/ml

Administreringsrute:

INTRAVENOUS

Resept typen:

Prescription Only

Produsert av:

HOSPIRA INC

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2003-02-14

Informasjon til brukeren

ZEMPLAR
TM 

(Paricalcitol Injection) 

DESCRIPTION  

Paricalcitol injection is a synthetically manufactured,
metabolically active vitamin D analog with 
modifications to the side chain (D2) and the A (19-nor) ring. It
is available as a sterile, clear, colorless, 
aqueous solution for intravenous injection. Each 1 mL
contains paricalcitol, 5 mcg; propylene glycol, 
30% (v/v); and alcohol (ethanol), 20% (v/v).  

Paricalcitol is a white,
crystalline powder with empirical formula C
27
H
44
O
3
, which corresponds to a 
molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-
1α,3β,25-trihydroxy-9,10 
secoergosta5(Z),7(E),22(E)-triene.  

PHARMACOLOGIC PROPERTIES 

PHARMACODYNAMIC PROPERTIES 

Secondary hyperparathyroidism is characterized by an elevation
in parathyroid hormone (PTH) 
associated with inadequate levels of active vitamin D
hormone. The source of vitamin D in the body is 
from synthesis in the skin as vitamin D
3
and from dietary intake as either Vitamin D
2
 or D
3
. Both 
Vitamin D
2
 and D
3
 require two sequential hydroxylations in
the liver and the kidney to bind to and to 
activate the vitamin D
receptor (VDR). The endogenous VDR activator, calcitriol [1,25(OH)
2
D
3
], is a 
hormone that binds to VDRs that are present in the
parathyroid gland, intestine, kidney, and bone to 
maintain parathyroid function and calcium and
phosphorus homeostasis, and to VDRs found in many 
other tissues, including prostate, endothelium and immune cells. VDR
activation is essential for the 
proper formation and
maintenance of normal bone. In the diseased kidney, the
activation of vitamin D 
is diminished, resulting in a rise of PTH,
subsequently leading to secondary hyperparathyroidism and 
disturbances in the calcium and phosphorus homeostasis.
1
 Decreased levels of 1,25(OH)
2
D
3
 have 
been obse

Preparatomtale

ZEMPLAR
TM
(Paricalcitol Injection)
DESCRIPTION
Paricalcitol injection is a synthetically manufactured, metabolically
active vitamin D analog with
modifications to the side chain (D2) and the A (19-nor) ring. It is
available as a sterile, clear, colorless,
aqueous solution for intravenous injection. Each 1 mL contains
paricalcitol, 5 mcg; propylene glycol,
30% (v/v); and alcohol (ethanol), 20% (v/v).
Paricalcitol is a white, crystalline powder with empirical formula C
27
H
44
O
3
, which corresponds to a
molecular weight of 416.64. Paricalcitol is chemically designated as
19-nor-1α,3β,25-trihydroxy-9,10
secoergosta5(Z),7(E),22(E)-triene.
PHARMACOLOGIC PROPERTIES
PHARMACODYNAMIC PROPERTIES
Secondary hyperparathyroidism is characterized by an elevation in
parathyroid hormone (PTH)
associated with inadequate levels of active vitamin D hormone. The
source of vitamin D in the body is
from synthesis in the skin as vitamin D
3
and from dietary intake as either Vitamin D
2
or D
3
. Both
Vitamin D
2
and D
3
require two sequential hydroxylations in the liver and the kidney to
bind to and to
activate the vitamin D receptor (VDR). The endogenous VDR activator,
calcitriol [1,25(OH)
2
D
3
], is a
hormone that binds to VDRs that are present in the parathyroid gland,
intestine, kidney, and bone to
maintain parathyroid function and calcium and phosphorus homeostasis,
and to VDRs found in many
other tissues, including prostate, endothelium and immune cells. VDR
activation is essential for the
proper formation and maintenance of normal bone. In the diseased
kidney, the activation of vitamin D
is diminished, resulting in a rise of PTH, subsequently leading to
secondary hyperparathyroidism and
disturbances in the calcium and phosphorus homeostasis.
1
Decreased levels of 1,25(OH)
2
D
3
have
been observed in early stages of chronic kidney disease. The decreased
levels of 1,25(OH)
2
D
3
and
resultant elevated PTH levels, both of which often precede
abnormalities in serum calcium and
phosphorus, affect bone turnover rate and may result